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The goal of this clinical trial is to learn if Neem works to treat Oral Lichen Planus in adults. It will also learn about the safety of Neem in oral lesions. The main questions it aims to answer are:
To compare the efficacy of 1.5% Neem Gel (Azadirachta Indica) versus 0.1% Triamcinolone Acetonide in treatment of Oral Lichen Planus (OLP) as a topical treatment modality for patients with OLP,
Researchers will compare Neem to a corticosteroid (a standard treatment for Oral Lichen Planus) to see if Neem works to treat Oral Lichen Planus.
Participants:
In experimental group were given Neem Gel in Orabase formulations and control group with topical Triamcinolone acetonide oral paste to be used twice every day for 3 months Visit the clinic once every month for checkups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neem | Experimental |
| |
| Triamcinolone Acetonide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neem gel | Drug | 1.5% Neem Gel in orabase formulation, twice daily application for 3 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale | Burning sensation will be evaluated with Visual Analogue scale | From enrollment to the end of 3 months |
| Thongprasom's Score | clinical severity of lesion | From enrollment to the end of the 3 months |
| OLP Disease Severity Score | Site, size and severity of lesion | From enrollment to the end of 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Anxiety and Depression Scale | Anxiety and depression evaluation among patients | From Enrollment to the end of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oral Medicine and radiology, Goa Dental College and Hospital, Bambolim Goa India | Goā | Bambolim | 403202 | India |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Triamcinolone Acetonide |
| Drug |
0.1% oral paste to be applied twice daily for 3 months |
|
| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |